Localization of Nonpalpable Breast Lesions

Breast Cancer Clinical Trial

Official title:

A Randomized Study of Localization of Nonpalpable Breast Lesions - RSL vs WGL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01901991
• Other study ID #: R72-A4701-13-S9
• Status: Completed
• Phase: N/A
• First received: July 14, 2013
• Last updated: August 9, 2017
• Start date: January 2014
• Est. completion date: February 2016

Study information

• Verified date: September 2016
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Each year the Danish mammography-screening programme identifies a large number of patients with small non-palpable breast cancers or precancerous lesions. The majority of these patients are suitable for breast conserving surgery (BCS). The object of BCS is to remove the suspicious lesion completely without removing excess healthy breast tissue. To obtain this accurate lesion localization is essential.

Until today the standard procedure in Denmark has been wire guided localization (WGL). Although the method has been utilized for a number of years it has several disadvantages. Often inaccurate lesion localization leads to incomplete lesion removal (positive margin) and subsequently reoperation. It can postpone the additional systemic treatment, offered after the operation. Other disadvantages are poor cosmetic outcome and inconvenient planning for the patient and the departments involved. The wire needs to be placed on the day of the operation, which decreases the flexibility of the procedure.

The purpose of this study is to test a new method named radioactive seed localization (RSL). The method uses a small titanium seed containing radioactive iodine. It will be placed in the centre of the lesion, and during the operation, the surgeon can locate it with a handheld gamma probe. The seed can be placed a few days in advance, which means a more flexible course of treatment. The method seems promising with regards to reoperation rates, but it needs further testing.

Hypothesis:

RSL is a more accurate method, for localization of nonpalpable breast lesions, than WGL. Using RSL obtains, to a great extent, adequate negative margins, resulting in a reduced number of re-operations.

The study will be performed as a randomised clinical trial, where the two methods will be compared to each other. The trial will be performed at the department of breast surgery at Rigshospitalet and include patients with nonpalpable breast lesions. Besides reoperation rates, duration of the surgical procedure and the amount of removed breast tissue will be compared.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 410
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with nonpalpable breast lesions, carcinoma in situ or invasive carcinoma, where preoperative lesion localization is necessary.

• All age groups, minimum 18 years

Exclusion criteria:

• Patients with benign nonpalpable breast lesions.

• Patients who are unable to comprehend the information.

• Patients who are pregnant, breastfeeding or have children < 3 years.

• Patients who have lesions, which requires more than two wires or seeds for localization.

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma in Situ

Intervention

Procedure:
• Radioactive seed localization (RSL)
Localization of nonpalpable breast lesions with Radioactive seed localization
• Wire-guided localization (WGL)
Localization of nonpalpable breast lesions with Wire-guided localization

Locations

Country	Name	City	State
Denmark	Rigshospitalet (Copenhagen University Hospital)	Copenhagen	Østerbro

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Langhans L, Tvedskov TF, Klausen TL, Jensen MB, Talman ML, Vejborg I, Benian C, Roslind A, Hermansen J, Oturai PS, Bentzon N, Kroman N. Radioactive Seed Localization or Wire-guided Localization of Nonpalpable Invasive and In Situ Breast Cancer: A Randomiz — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of the surgical procedure.		3 months.
Primary	Re-operation rate due to positive microscopic margins detected at the final pathological evaluation.		Re-operation within 3 months after the initial breast conserving surgery.
Secondary	Amount of excised breast tissue in relation to tumour size.		3 months.